| CTRI Number |
CTRI/2021/11/038058 [Registered on: 15/11/2021] Trial Registered Prospectively |
| Last Modified On: |
15/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate relation between Rheumatoid arthritis and prakruti. |
|
Scientific Title of Study
|
An Observational survey study to evaluate relation between Rheumatoid arthritis and prakruti. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suchitra Ghanwat |
| Designation |
PG scholar |
| Affiliation |
College of Ayurveda and research center Nigdi Pune |
| Address |
At. Post. Pimprad Tal. Phaltan Dist. Satara.
Satara
MAHARASHTRA
415523
India |
| Phone |
8390451907 |
| Fax |
|
| Email |
suchitraghanwat13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Chobhe |
| Designation |
Head of department |
| Affiliation |
College of Ayurved and research centre, Nigdi |
| Address |
College of Ayurved and Research Centre Akurdi Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9850716124 |
| Fax |
|
| Email |
swatichobhe@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suchitra Ghanwat |
| Designation |
PG scholar |
| Affiliation |
College of Ayurveda and research center Nigdi Pune |
| Address |
At. Post. Pimprad Tal. Phaltan Dist. Satara.
Satara
MAHARASHTRA
415523
India |
| Phone |
8390451907 |
| Fax |
|
| Email |
suchitraghanwat13@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Ayurveda and research center Nigdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
College of Ayurveda and research center Nigdi Pune |
| Address |
Sector 25, Nigdi, Pune-411044 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suchitra Ghanwat |
Ayurved Rugnalaya and Sterling Multispeciality Hospital |
Vitthal Rukhumai Road Sector No. 27,Ground floor, Pradhikaran, Nigdi,Pimpri chinchwad Pune-411044.
Pune
MAHARASHTRA |
8390451907
suchitraghanwat13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Known Cases of Rheumatoid arthritis |
|
| ExclusionCriteria |
| Details |
Patient Consuming Steroids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conclusion will be strictly based on statistical analysis. |
Every 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Which Prakruti is more prone for Rheumatoid arthritis. |
Every 6 months. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prevalence rate of Rheumatoid Arthritis has increased because of unhealthy lifestyle, environmental factors etc. In this context, Ayurvedic Prakruti Examination may prove to be useful, if the doctor knows which type Prakruti is more prone for Rheumatoid arthritis, then preventive measures can be taken as per Prakruti of a patient. Thus present research will be a boon both for patient and the doctor. |